FDA Adverse Event
Injury
Summary report: N
SOFTFORM FACIAL IMPLANT
MDR report key: 192740
·
Received October 19, 1998
Report
- Report Number
- 2027148-1998-00089
- Event Type
- Injury
- Date Received
- October 19, 1998
- Date of Event
- June 8, 1998
- Report Date
- October 19, 1998
- Manufacturer
- TISSUE TECHNOLOGIES, INC.
- Product Code
- FTL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT IMPLANTED IN UPPER AND LOWER VERMILION BORDERS AND NASOLABIAL FOLDS 05/07/1998. ONSET OF IMPLANT EXTRUSION IN PERIORAL AREA 06/08/1998. AREA INCISED AND DRAINED 06/08/1998. KEFTAB PRESCRIBED 06/08/1998. IMPLANT EXPLANTED 06/11/1998.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFTFORM FACIAL IMPLANT Implant | SOFTFORM | FTL | TISSUE TECHNOLOGIES, INC. | NA | K03541/97L101A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Required Intervention | 1. KEFTAB (05/07/1998 TO 05/13/1998)| 2. VICODIN (TO 05/07/1998) |